ABSTRACT
The New Approach concept [8] is a legislative-technical frame for harmonization in Europe: it is to link industrials and regulators for harmonization for the elaboration of Directives and Technical Standards. Using the New Approach for market access results in most of the cases by having a product recognized by a European Conformity (CE) mark. However, among the Directives (around 20; Table 21.2) which adopt the New Approach, some did without the CE mark like the Directive 94/62/EC on waste and packaging. The New Approach concept (Fig. 21.2) was established in 1985 and resulted in the elaboration of European Directives, which are based on the following principles: • Only products fulfilling the essential requirements may be placed on the market and put into service. • Harmonized standards, the reference numbers of which have
been published in the Official Journal and which have been transposed into national standards, are presumed to conform to the corresponding essential requirements. • Application of harmonized standards or other technical specifications remains voluntary, and manufacturers are free to choose any technical solution that provides compliance with the essential requirements.
